Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bococizumab for lipid lowering in asian hypercholesterolemia subjects

Conditions: Primary Hyperlipidemia or Mixed Dyslipidemia

Summary: this study is a phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg sc q2wks to placebo for ldl-c lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for cv events. the study will enroll a total of approximately 750 subjects from 4 - 5 asian countries/areas (including china mainland); of which approximately 600 subjects will be from sites in china. subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.

after providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. eligible subjects will be considered enrolled and progress to the randomization visit. results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. subjects will attend clinic visits as shown in the schedule of activities. subjects will be randomized to receive either 150 mg q2wks of bococizumab or placebo in a 1:1 ratio. lipid levels will be blinded to the investigator and staff, subject and sponsor.

Eligibility criteria:
inclusion criteria: * males and females at the age or over 18 years of age. * with primary hyperlipidemia or mixed dyslipidemia. * treated with stable daily dose of statins * at high or very high risk of incurring a cv event * fasting ldl-c \>=70 mg/dl (1.81 mmol/l) for subjects on the highest approved dose of statins; fasting ldl c \>=77 mg/dl (1.99 mmol/l) for subjects not on highest approved dose. * fasting tg ≤400 mg/dl (4.51 mmol/l) exclusion criteria: * prior exposure to bococizumab or other investigational pcsk9 inhibitor * nyha class iv, or left ventricular ejection fraction \<25% * poorly controlled hypertension * history of hemorrhagic stroke or lacunar infarction resulting in a stroke * untreated hyperthyroidism or tsh \>1 × uln * undergoing apheresis or have planned start of apheresis.
a multicenter, randomized, double-blind, double-dummy trial of azithromycin sr compared with levofloxacin for the treatment of mild to moderate pneumonia in adult patients

Conditions: Pneumonia

Summary: the study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (sr) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.


Eligibility criteria:
inclusion criteria: patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included. exclusion criteria: key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
the effect of acute concurrent exercise on executive function: an event-related potential study

Conditions: Executive Function

Summary: executive function is a high-level cognition which plays an important role in our life. meta-analysis study has demonstrated that acute exercise could improve executive function. however, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. it is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. therefore, the purposes of present study are: (1) measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate.

executive function is a high-level cognition which plays an important role in academic performance, career, and interpersonal relationship. meta-analysis study has demonstrated that acute exercise could improve executive function, and also observed similar positive effect through both aerobic and resistance exercise. however, it is still unclear whether executive function can be enhanced by the concurrent exercise that combines aerobic and resistance exercise. moreover, previous studies indicated that acute exercise could increase the concentration of blood lactate which is positive correlated to executive function. it is still unclear whether the effect of acute concurrent exercise on executive function is mediated by blood lactate. therefore, the purposes of present study are: (1) measuring the effect of acute concurrent exercise and aerobic exercise on executive function. (2) measuring whether the effect of acute concurrent exercise on executive function is mediated by blood lactate.

Eligibility criteria:
inclusion criteria: 1. no history of psychiatric or neurological disorders 2. no history of cardiovascular disease 3. normal or corrected to normal vision and normal color perception 4. right handed 5. 18.5 \< bmi \< 27 exclusion criteria: 1. diagnosed with epilepsy

Keywords: acute exercise concurrent exercise cognitive flexibility
bovine lactoferrin in reducing taste disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy

Conditions: Colorectal Cancer; Dysgeusia; Oral Complications of Chemotherapy

Summary: the purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.

primary objectives: i. to assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy secondary objectives: i. to assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (tbars) assay. ii. to assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution. iii. to assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in patients with established chemotherapy-induced taste disturbances. iv. to assess the incidence of vitamin d deficiency in patients with oxaliplatin-based therapy induced taste changes outline: patients receive bovine lactoferrin orally (po) (rinse or tablet) thrice daily (tid) for 1 month. treatment continues in the absence of unacceptable toxicity. after completion of study treatment, patients are followed up at 2 and 4 weeks.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed colorectal carcinoma * there are no restrictions on the amount or types of prior therapy * eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial * any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either: * 1) developed since the initiation of oxaliplatin-based therapy, or * 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy * patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma * life expectancy of \>= 3 months * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 ml in 15-20 min) * patients known to be human immunodeficiency virus (hiv)-positive * patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis * patients who are known to be pregnant or who are breastfeeding are excluded
safety & performance study of verruca treatment device

Conditions: Verruca; Plantar Wart

Summary: this is a non comparative pre-ce marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the verruca treatment - npd396, class iia medical device for verrucas in the adult population. the treatment regime will be topical application of the verruca treatment to the verruca, identified as the reference, once daily for 4 weeks. patient \& investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile. patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. compliance with treatment schedule will be collected via patient diary cards. furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 \& 28 days after starting treatment. diary cards will completed through-out the investigation.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>18 years * patients with verrucas * patients should be willing to take part, able to understand the information given to them and give written consent exclusion criteria: * patient with more than two areas affected by verrucas on one foot * patient who are actively treating or have treated their wart within the past 8 weeks * patient suspected to be immunocompromised or are taking immunosuppressants * patient who suffer from impaired feeling due to diabetes, peripheral vascular disease or neuropathy. * current participation in another clinical investigation or participation within the last 30 days. * patient with known sensitivity/allergies to the test materials or any of their ingredients. * significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the investigator, would compromise the safety of the volunteer or affect the outcome of the investigation (as determined from self-reported medical history questionnaire). * patient in a situation which in the view of the investigator could interfere with optimal participation in the investigation or constitute a special risk for these patients. * patient who scar easily or are prone to hypertrophic or keloid scarring. * patient who have previously had an unfavourable reaction to any products for the feet and which involved swelling of the foot, or a requirement for painkillers or antibiotics. * pregnant and lactating females, or those actively seeking to become pregnant in the next month

Keywords: verruca plantar wart medical device podiatry footcare
implementing technology-assisted drug treatment and relapse prevention in federally qualified health centers (fqhcs)

Conditions: Substance Use Disorders; HIV

Summary: implementing a mobile-phone based system for drug use disorders in primary care settings.

the purpose of the research is to study the impact of a recovery support system called seva on primary care organizations, where issues such as coordination of care, job satisfaction, and the cost of adopting and operating new technologies are critical. the study will also investigate how to best implement this kind of technology into health care delivery systems that care for people diagnosed with substance abuse.

Eligibility criteria:
inclusion criteria: patient subjects must be 1) age 18 or older 2) meet criteria for substance use disorder (sud) according to the clinic. clinician subjects referring patients will ensure that patients: 3) have no current psychotic disorder severe enough to prevent participation, 4) have no acute medical problem requiring immediate inpatient treatment, 5) are willing to use seva, and 6) can understand and sign a consent form in english. clinician subjects include mds, behavioral health providers, nurses and management staff from the clinics' primary care and behavioral health departments. clinician must have an interest in the research objectives. exclusion criteria: * failure to meet inclusion criteria above will exclude patients and clinicians from participating.
r3 delta ceramic acetabular system pas u.s.

Conditions: Degenerative Joint Disease

Summary: r3 delta post-approval study u.s.

post-approval study of the r3 biolox delta ceramic acetabular system - us the r3 ceramic acetabular system is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. the expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

Eligibility criteria:
inclusion criteria: * patient is 18-75 years old and he/she is skeletally mature * patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. * patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk * patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires * patient has consented to participating in the study by signing the irb/ec approved informed consent form exclusion criteria: * patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis * patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint * patients with active joint infections or chronic systemic infection * obese patients where obesity is defined as bmi ≥ 40 * skeletal immaturity * known allergy to implant materials

Keywords: primary total hip arthroplasty non-inflammatory arthritis degenerative joint disease r3 delta ceramic acetabular insert
effectiveness of dry needling of the gastrocnemius muscle vs electrolysis in subjects with achilles tendinopathy

Conditions: Achilles Tendinopathy; Pain

Summary: achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. to observe the effectiveness of dry needling in the pgm of the gastrocnemius muscle, in the short and medium term, on the intensity of pain in gastrocnemius muscle, in the short and medium term, on pain intensity in patients with patients with achilles tendinopathy, compared to the application of ultrasound-guided percutaneous electrolysis on the tendon.


Eligibility criteria:
inclusion criteria: * signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques. * presence of symptoms (swelling or pain) for at least 3 months. * positive achilles tendon palpation test. * males and females over 18 years of age. * presence of mmp in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by travell and simons: * presence of palpable tight band. * local pain on pressure at the nodule of the tense band. * recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule. * limitation of range of motion. exclusion criteria: * any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study

Keywords: achilles tendon electrolysis tendinopathy
traumatic brain injury and yoga

Conditions: Traumatic Brain Injury

Summary: this long-term goal of this project was to advance best practices in occupational therapy in conjunction with yoga. to address the long-term goal, this research team developed a pilot yoga intervention. the intervention was designed to focus on balance, balance confidence, body responsiveness, pain, physical ability and quality of life. assessments were then chosen to address these areas pre and post yoga intervention. a manual and protocol were developed for the intervention and then the intervention was implemented with a group of individuals with chronic traumatic brain injury.

this was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility and efficacy of yoga for individuals with chronic traumatic brain injury. the study was a mixed-methods longitudinal study. assessments were conducted 8 weeks prior to the yoga intervention and then just following the 8 week yoga intervention. the objectives of this feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga for the traumatic brain injury intervention and 2) assess change in balance, balance confidence, body responsiveness, pain, physical ability, and quality of life.

Eligibility criteria:
inclusion criteria: * chronic tbi (\>6 months) * greater than or equal to 18 years of age * no consistent practice of yoga in the last year exclusion criteria: * inability to provide informed consent * less than 18 years of age * self-report of exercise restriction * consistent yoga practice within the last year * inability to attend sessions based on transportation restrictions

Keywords: yoga traumatic brain injury
to demonstrate the relative bioavailability of cetirizine hydrochloride/pseudoephedrine hydrochloride 5 mg/120 mg extended release (er) tablets under fed conditions

Conditions: Allergies

Summary: to demonstrate the relative bioavailability of cetirizine hydrochloride/pseudoephedrine hydrochloride 5 mg/120 mg er tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
acupressure and fistula needle insert pain management

Conditions: Chronic Kidney Disease Stage 5 (Disorder)

Summary: introduction: this study was conducted to determine the effectiveness of acupressure application on hegu (li4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula. methods: this study was randomized control study which was conducted with 66 intervention and 65 control participants. the participants in the intervention group were divided into 3 groups according to the fistula area. data were collected using descriptive information form and pain scale.

this study is determined that finger acupuncture at l14 point reduces the severity of pain felt by the patient during fistula needle insertion. acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. moreover, patients experience this acute pain three times a week. accordingly, acupressure applied to the l4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. in addition, in this article, we examined the effect of acupressure applied only to the li4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).

Eligibility criteria:
inclusion criteria 18 years or older have brescia-cimino, snuff-box or antecubital fistula speak turkish have hemodialysis(hd) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study. exclusion criteria with aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.
evaluation of hydrogen peroxide and hyaluronic acid (bmg0703) in the healing of post-extraction sites

Conditions: Impacted Third Molar Tooth; Healing Surgical Wounds

Summary: a clinical study to evaluate the efficacy and safety of a mouthwash containing hydrogen peroxide, sodium hyaluronate and glycine in the healing of post-extraction sites of wisdom teeth by film forming action.

57 subjects, with an indication for a third molar extraction, will be enrolled in the study. participants selection will take place at the irccs "ca" granda ospedale maggiore policlinico of milan - uoc surgery maxillo facial and dentistry where the internship activity of the degree course in dentistry and dental prosthetics, dental hygiene and the school of specialization in orthodontics of the university of milan is held. subsequently, subjects will be equally divided and randomly assigned into the test or control groups. assessment of outcomes will be carried out at a distance of 7 days.

Eligibility criteria:
inclusion criteria: * acceptance of informed consent * need to carry out extraction of a third molar in total or partial impaction exclusion criteria: * subjects suffering from hiv * subjects suffering from hepatitis * serious systemic diseases preventing the use of specific dental therapies * acute and/or chronic infectious diseases * inability to provide consent

Keywords: impacted third molar tooth surgical wound healing bleeding